Prospective Randomized Endovascular Therapy in Multiple Sclerosis - PREMiSE

Multiple Sclerosis Clinical Trial

— PREMiSE  

Official title:

Prospective Randomized Endovascular Therapy in Multiple Sclerosis - PREMiSE

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01450072
• Other study ID #: NSG1730210B
• Status: Completed
• Phase: Phase 2
• First received: October 6, 2011
• Last updated: May 10, 2016
• Start date: June 2010
• Est. completion date: December 2012

Study information

• Verified date: May 2016
• Source: University at Buffalo Neurosurgery
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The Departments of Neurology and Neurosurgery are conducting this research study to evaluate the safety and effectiveness of intravascular angioplasty for the treatment of venous narrowing in the treatment of Multiple Sclerosis (MS).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Age 18-65 years

• EDSS 0-6.5 (0-5.5 in the phase II of the study)

• Diagnosis of relapsing MS according to the McDonald criteria (Polman et al., 2005)

• 1 relapse within the past 12 months or GAD positive lesion on an MRI within the past 3 months (only for phase II of the study)

• Be on treatment with currently FDA approved disease-modifying treatments (excluding Tysabri or steroids (within the last 30 days prior to enrollment)

• Evidence of =2 sonographic parameters of suspicious abnormal extracranial cerebral venous outflow (see Table 1 background and 1.5 section)

• Normal renal function: creatinine clearance level of >60

Exclusion Criteria:

• Relapse, disease progression and Tysabri and steroid treatment in the 30 days preceding study entry

• Pre-existing medical conditions known to be associated with brain pathology (e.g., neurodegenerative disorder, cerebrovascular disease, positive history of alcohol abuse, etc.)

• Severe peripheral chronic venous insufficiency

• Abnormal renal function

• Contrast allergy (anaphylaxis)

• Not accepting to undergo the endovascular treatment

• Peripheral Vascular Disease

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Device:
• Selective Venography followed by therapeutic balloon angioplasty
Venography followed by therapeutic balloon angioplasty

Other:
• Control arm
Venography and sham angioplasty

Locations

Country	Name	City	State
United States	University at Buffalo Neurosurgery	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
University at Buffalo Neurosurgery

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety	- Percent (%) of patients with Severe Adverse Events (SAE) measured at 24 hours (Immediate) and 1 month (Short term) post-surgical safety outcome in MS patients diagnosed with CCSVI that underwent therapeutic angioplasty. . The 95% confidence interval of the SAE rates for immediate and short terms will be obtained by the exact method, respectively. For Phase II study, the immediate and short term SAE rates will be analyzed, respectively, using the Fisher's exact test.	24 hours-1 month	Yes
Secondary	Preliminary efficacy	- Restoration of venous outflow (more than 75% of normal outflow) as measured by the combined ECD/TCD and MRV at 1 month, 3 months, 6 months, and 1 yearfollowing the angioplasty as compared to baseline as well as compared to a parallel control group of MS patients that will undergo only selective venography without balloon angioplasty (sham-angioplasty). These comparisons will be accomplished by the hierarchical linear model which takes into account the correlation within subjects. Based on the residuals, we will check the normality assumptions by the normal quantile plot and skewness.	1 month, 3 months, 6 months, and 1 yearfollowing	No